Lifting and Tightening of the Face in Subjects With Skin of Darker Color

Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Cheek Tissue and Improvement in Jawline Definition and Submental Skin Laxity in Patients With Fitzpatrick Skin Phototypes 3 Through 6

This prospective, multi-center, single treatment clinical trial evaluates the clinical outcomes associated with non-invasive treatment to obtain lift and tightening of facial tissue and improve jawline definition in subjects with darker skin color utilizing the Ulthera® System to deliver focused ultrasound energy below the skin surface.

The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System for the non-invasive treatment to obtain overall lift and tightening of facial tissue and jawline definition improvement.

Inclusion Criteria:

• Male or female, aged 30 to 65 years.
• Subject in good health.
• Subjects who desire lift and tightening of cheek tissue, improvement in jawline definition and/or submental skin laxity.
• Fitzpatrick skin phototypes of 3 through 6.
• Provide written informed consent and HIPAA authorization

Exclusion Criteria:

• Pregnant or lactating.
• Presence of an active systemic or local skin disease that may affect wound healing.
• Severe solar elastosis.
• Excessive subcutaneous fat on the cheek.
• Excessive skin laxity on the lower face and neck.
• Significant scarring in areas to be treated.
• Significant open facial wounds or lesions.
• Severe or cystic acne on the face.
• Presence of a metal stent or implant in the facial area to be treated.